| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00114-1 |
| Product Name/Description |
Ceramic Insertion Tool Assembly (Supplied as part of the reusable orthopaedic surgical procedure kit)
Catalogue number: 2216-0005
All lot numbers are affected
ARTG Number: 140892 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Preliminary testing by Stryker Orthopaedics indicates that some silicone suction cup sub-component were manufactured from a non-silicone polymer, polyvinyl chloride (PVC) and that these PVC cups contain latex. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is requesting customers to identify and remove any affected stock until the units can be collected or returned to Stryker |
| Contact Information |
1800 803 601 - Stryker Regulatory Affairs |